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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-001174-81
    Sponsor's Protocol Code Number:D07-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-001174-81
    A.3Full title of the trial
    RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB
    A.3.2Name or abbreviated title of the trial where available
    LAP 07
    A.4.1Sponsor's protocol code numberD07-1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorULB Erasme Hospital
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameErlotinib (DCi) chlorhydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameErlotinib (DCi) chlorhydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameErlotinib (DCi) chlorhydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC classification) and not considered for curative resection after pluridisciplinary discussion.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052747
    E.1.2Term Adenocarcinoma pancreas
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether administrating a chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared to continue the same CT.
    E.2.2Secondary objectives of the trial
    - To assess whether erlotinib combined with gemcitabine and administered as maintenance treatment increases overal survival compared to gemcitabine alone and without maintenance.
    - To assess whether administrating a chemoradiotherapy (CRT) in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases progression free survival compared to continue the same CT.
    - To assess whether erlotinib combined with gemcitabine and administrated as maintenance treatment increases progression free survival compared to gemcitabine alone with and without maintenance.
    - To evaluate the response rate in the CT and CRT arms.
    - To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancilliary study 1: "for all included patients in countries for whom the methodology can be performed locally"
    The aim is to to study the predictive molecular factors (survivin, K-ras, EGFR, PTEN, AKT) on survival "for all included patients in countries where the methodology can be performed locally.
    There are very few studies on the prognostic value of genetic modifications in the response to treatment with gemcitabine and erlotinib.
    The study will evaluate the status of the apoptotic genes (survivin, bcl-2) and the signalling pathways PI3K:AKT:mTor (K-ras, EGFR, PTEN, AKT) to try and define prognostic factors (delay before development of metastases) and response to proposed treatments)

    Ancilliary study 2: only in France
    The aim is to define the prognostic impact of circulating tumor cell detection.
    Extravasation and circulating within blood vessels is an essential step of the metastatic process. The detection of CTC has been proved to be a significant pejorative prognostic factor in some types of cancers, where decrease in CTC count under chemotherapy is correlated to tumor response and patient survival.
    As tumor biopsies are uneasy and dangerous in pancreatic cancer, CTC should be used as "surrogate biomarkers" of the tumor biology.
    E.3Principal inclusion criteria
    1. Age older than ≥ 18
    2. Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC 2002 classification) and not considered for curative resection after pluridisciplinary discussion.
    3. ECOG Performance Status ≤ 2
    4. Estimated life expectancy ≥ 12 weeks
    5. No prior radiotherapy nor chemotherapy for any reason
    6. Signed informed consent form
    7. Polynuclear neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL
    8. Total bilirubin ≤1.5 N (N: upper limit of normal). In patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 N (50 µmoles/L) is acceptable.
    9. AST and ALT ≤ 2.5 N, alkaline phosphatase ≤ 5 N
    10. Albumin ≥ 25 g/L
    11. Creatinin ≤ 177 µmol/L (2 mg/dL)
    12. Female patients who are not menopausal and their partners must accept to use effective contraception throughout treatment and for 3 months after the end of treatment. All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.
    E.4Principal exclusion criteria
    1. Localized cancer stage IA to IIB or metastatic cancer (stage IV) according to UICC 2002
    2. Previous chemotherapy for any reason
    3. Previous abdominal radiotherapy
    4. Allergy to one of ingredients in erlotinib
    5. Prior treatment with an anti-EGFR
    6. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the uterus or basal cell skin cancer.
    7. Severe infection
    8. Ophthalmic disease (inflammation, keratopathy or infection)
    9. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the last 6 months.
    10. Unable to take oral treatments or with gastrointestinal disorders that could be associated with absorption disorders, untreated gastric or duodenal ulcer.
    11. Pregnancy or breast feeding
    12. Unable to follow for psychological, familial or geographic reasons.
    13. Not affiliated with a social security regime.
    14. Diarrhea ≥ grade 2 and/or uncontrolled diarrhoea
    15. Ampulloma and carcinoma of the periampullary region
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival
    Survival will be assessed from the date of the first randomization to the date of patient death, due to any cause, or to the last date the patient was known to be alive. Patients who were not reported as having died at the time of the analysis will be censored using the date they were last known to be alive.

    2. Progression Free Survival
    Progression-free survival (PFS) is the time from the date of the first randomization to the date of progressive disease (RECIST criteria) or death.
    Death will be regarded as a progression event in those patients who die before disease progression. Patients without documented objective progression at the time of the final analysis will be censored at the date of their last objective tumor assessment.

    3. Definition of Response
    The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria will be used for this trial for objective tumor response assessment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last patient inclued in the study then 1 year of follow up for all patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months58
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 680
    F.4.2.2In the whole clinical trial 902
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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